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Package leaflet: Information for the patient

Atovans 10 mg film-coated tablets

Atovans 20 mg film-coated tablets

Atovans 40 mg film-coated tablets


Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

What is in this leaflet

1. What Atovans is and what it is used for

2. What you need to know before you take Atovans

3. How to take Atovans

4. Possible side effects

5. How to store Atovans

6. Contents of the pack and other information

1. What Atovans is and what it is used for

Atovans belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines.

Atovans is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atovans can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment.

2. What you need to know before you take Atovans

Do not take Atovans

if you are allergic to atorvastatin or to any similar medicines used to lower blood lipids or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Atovans.

The following are reasons why Atovans may not be suitable for you:

Check with your doctor or pharmacist before taking Atovans

if you have severe respiratory failure.

If any of these apply to you, your doctor will need to carry out a blood test before and possibly during your Atovans treatment to predict your risk of muscle related side effects. The risk of muscle related side effects e.g. rhabdomyolysis is known to increase when certain medicines are taken at the same time (see Section 2 “Other medicines and Atovans”)

While you are on this medicine your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are likely to be at risk of developing diabetes if you have high levels of sugars and fats in your blood, are overweight and have high blood pressure.

Other medicines and Atovans

There are some medicines that may change the effect of Atovans or their effect may be changed by Atovans. This type of interaction could make one or both of the medicines less effective. Alternatively it could increase the risk or severity of side-effects, including the important muscle wasting condition known as rhabdomyolysis described in Section 4:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Atovans with food, drink and alcohol

See Section 3 for instructions on how to take Atovans. Please note the following:

Grapefruit juice

Do not take more than one or two small glasses of grapefruit juice per day because large quantities of grapefruit juice can change the effects of Atovans.


Avoid drinking too much alcohol while taking this medicine. See Section 2 “Warnings and precautions” for details


Do not take Atovans if you are pregnant, or if you are trying to become pregnant.

Do not take Atovans if you are able to become pregnant unless you use reliable contraceptive measures.

Do not take Atovans if you are breast-feeding.

The safety of Atovans during pregnancy and breast-feeding has not yet been proven. Ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Normally this medicine does not affect your ability to drive or operate machines. However, do not drive if this medicine affects your ability to drive. Do not use any tools or machines if your ability to use them is affected by this medicine.

Atovans contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3. How to take Atovans

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Before starting treatment, your doctor will place you on a low-cholesterol diet, which you should maintain also during therapy with Atovans.

The recommendedstarting dose of Atovans is 10 mg once a day in adults and children aged 10 years or older. This may be increased if necessary by your doctor until you are taking the amount you need. Your doctor will adapt the dose at intervals of 4 weeks or more. The maximum dose of Atovans is 80 mg once daily for adults and 20 mg once daily for children.

Atovans tablets should be swallowed whole with a drink of water, and can be taken at any time of day, with or without food. However, try to take your tablet at the same time every day.

The duration of treatment with Atovans is determined by your doctor.

Please ask your doctor if you think that the effect of Atovans is too strong or too weak.

If you take more Atovans than you should

If you accidently take too many Atovans tablets (more than your usual daily dose), contact your doctor or nearest hospital for advice.

If you forget to take Atovans

If you forget to take a dose, just take your next scheduled dose at the correct time. Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine or wish to stop your treatment, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious side effects, stop taking your tablets and tell your doctor immediately or go to the nearest hospital accident and emergency department.

Rare (may affect up to 1 in 1,000 people):

Serious allergic reaction which causes swelling of the face, tongue and throat that can cause great difficulty in breathing.

Serious illness with severe peeling and swelling of the skin, blistering of the skin, mouth, eyes genitals and fever. Skin rash with pink-red blotches especially on palms of hands or soles of feet which may blister.

Muscle weakness, tenderness or pain and particularly, if at the same time, you feel unwell or have a high temperature it may be caused by an abnormal muscle breakdown. The abnormal muscle breakdown does not always go away, even after you have stopped taking atorvastatin, and it can be life-threatening and lead to kidney problems.

Very rare (may affect up to 1 in 10,000 people):

If you experience problems with unexpected or unusual bleeding or bruising, this may be suggestive of a liver complaint. You should consult your doctor as soon as possible.

Other possible side effects with Atovans:

Common side effects (may affect up to 1 in 10 people) include:

Uncommon side effects (may affect up to 1 in 100 people) include:

Rare side effects (may affect up to 1 in 1,000 people) include:

Very rare side effects (may affect up to 1 in 10,000 people) include:

Not known: frequency cannot be estimated from the available data

muscle weakness that is constant.

Possible side effects reported with some statins (medicines of the same type):

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist.This includes any possible side effects not listed in this leaflet.You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Atovans

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light and moisture.

This medicine does not require any special temperature storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Atovans contains

What Atovans looks like and contents of the pack

10 mg film-coated tablets are white, round, slightly convex and bevel-edged, with diameter 6 mm.

20 mg film-coated tablets are white, round, slightly convex and bevel-edged, with diameter 8 mm.

40 mg film-coated tablets are white, round, slightly convex and bevel-edged, with diameter 10 mm.

Boxes of 4, 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 film-coated tablets in blisters packs are available.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

[To be completed nationally]

This leaflet was last revised in

21 January 2016